Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06100835
Status:
UNKNOWN
Last Update Posted:
2023-11-03
First Post:
2023-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of the JOIN4JOY Programme to Reduce Sedentary Behaviour and Increase Physical Activity in Older Adults.
Sponsor:
University of Vic - Central University of Catalonia
Organization:
Study Overview
Official Title:
Enjoy Physical Activity to Battle Sedentary Behaviour and Inactivity Among Older Adults From a Socially Inclusive Perspective (JOIN4JOY).
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JOIN4JOY
Brief Summary:
Physical activity (PA) and sedentary behavior (SB) programmes for older people in the community and long-term care facilities traditionally focus on achieving functional and health improvements. These approaches face frequent challenges in reaching older people with more social disadvantages and in achieving and maintaining attendance. The aim is to evaluate the acceptability, implementation process and potential impact of a co-created JOIN4JOY PA programme focused on enjoyment and social inclusion for 65+-year-old community-dwelling adults as well as for 65+-year-olds nursing-home residents who live in nursing homes.
Detailed Description:
Physical activity (PA) and sedentary behavior (SB) programmes for older people in the community and long-term care facilities traditionally focus on achieving functional and health improvements. These approaches face frequent challenges in reaching older people with more social disadvantages and in achieving and maintaining attendance. The aim is to evaluate the acceptability, implementation process and potential impact of a co-created JOIN4JOY PA programme focused on enjoyment and social inclusion for 65+-year-old community-dwelling adults as well as for 65+-year-olds nursing-home residents who live in nursing homes.
Two related multicentric, pragmatic, feasibility studies using mixed methods will be conducted. The programme consists of a novel, co-created PA intervention focusing on enjoyment and social inclusion, grounded in self-management strategies to promote behaviour change. Participants will be offered one weekly, 1-hour session of structured, supervised PA and encouraged to hold more active lifestyles and engage in autonomous physical activity practice. Group sessions will take place in the participant's nursing home or in collaborating social institutions in the community.
Participants will additionally be invited to join virtual communities of practice. At least 72 end-users will be recruited for each setting in 5 European countries (i.e., Spain, Denmark and Italy will focus on the community settings while and Spain, Germany, and France will do so inon nursing homes). The implementation process and its acceptability will be assessed for acceptability, fidelity, participation and satisfaction by means ofwill be assessed by semi-structured interviews, field diaries of sessions and quantitative 5-point Likert-type scales. To evaluate the potential impact, physical function (Short Physical Performance Battery test), quality of life (EUROQOL-5D scale), enjoyment (Physical Activity Enjoyment Scale), perceived improvement (Patient Global Impression of Improvement scale), activities of daily living (Barthel index) and SB patterns (accelerometers) will be assessed. SPSS software will be used for the analysis of quantitative variables with paired t-tests. Qualitative data collected . Ppre- and post-intervention changes will be assessed using determined themathematic analysis following the steps described by of qualitative data.will follow the Braun and Clarke steps.
Ethics and dissemination: A favorable report by the Research Ethics Committee of UVic-UCC (282/2023) was obtained on June 26th, 2023. Participation and withdrawal will be voluntary. When necessary, written permission by the legal guardian will be requested. A broad action of dissemination and communication activities will be targetting both the scientific and the general public.
Two related multicentric, pragmatic, feasibility studies using mixed methods will be conducted. The programme consists of a novel, co-created PA intervention focusing on enjoyment and social inclusion, grounded in self-management strategies to promote behaviour change. Participants will be offered one weekly, 1-hour session of structured, supervised PA and encouraged to hold more active lifestyles and engage in autonomous physical activity practice. Group sessions will take place in the participant's nursing home or in collaborating social institutions in the community.
Participants will additionally be invited to join virtual communities of practice. At least 72 end-users will be recruited for each setting in 5 European countries (i.e., Spain, Denmark and Italy will focus on the community settings while and Spain, Germany, and France will do so inon nursing homes). The implementation process and its acceptability will be assessed for acceptability, fidelity, participation and satisfaction by means ofwill be assessed by semi-structured interviews, field diaries of sessions and quantitative 5-point Likert-type scales. To evaluate the potential impact, physical function (Short Physical Performance Battery test), quality of life (EUROQOL-5D scale), enjoyment (Physical Activity Enjoyment Scale), perceived improvement (Patient Global Impression of Improvement scale), activities of daily living (Barthel index) and SB patterns (accelerometers) will be assessed. SPSS software will be used for the analysis of quantitative variables with paired t-tests. Qualitative data collected . Ppre- and post-intervention changes will be assessed using determined themathematic analysis following the steps described by of qualitative data.will follow the Braun and Clarke steps.
Ethics and dissemination: A favorable report by the Research Ethics Committee of UVic-UCC (282/2023) was obtained on June 26th, 2023. Participation and withdrawal will be voluntary. When necessary, written permission by the legal guardian will be requested. A broad action of dissemination and communication activities will be targetting both the scientific and the general public.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: